Efficacy of Standard Triple Therapy With or Without Statin in Helicobacter pylori Eradication: A Randomized Double-Blind Placebo-Controlled Trial

Background and aims: Standard triple therapy (STT) for Helicobacter pylori (H. pylori) infection has become suboptimal. Atorvastatin may improve eradication rates by promoting autophagy and reducing inflammation. This study aimed to evaluate the efficacy and safety of adjuvant atorvastatin with STT compared to STT alone for H. pylori eradication.

Methods

In this randomized, placebo-controlled trial, 138 treatment-naïve patients with H. pylori infection were randomized to two groups. The intervention group (n = 70) received a 14-day regimen of omeprazole, amoxicillin, clarithromycin, and atorvastatin (40 mg once daily). The control group (n = 68) received the same regimen with a matching placebo. The primary endpoint was H. pylori eradication, assessed by a urea breath test 4-6 weeks after treatment completion. Secondary endpoints included CYP2C19 and CYP3A4/5 genotypes, adverse events, and patient compliance.